Stealth BioTherapeutics Inc.
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Latest From Stealth BioTherapeutics Inc.
They’re Back! US FDA Panels Return To Normal And The Schedule Fills Up Fast
The US FDA is returning to the pre-COVID in-person advisory committee format and the agency suddenly has a flood of meetings lined up for the fall.
Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications
Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.
Keeping Track Of AdComms: US FDA Puts Donanemab On Schedule, Delays COVID-19 Meeting
Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.
Astellas Rejigs R&D Focus Areas As It Withdraws From Mitochondria R&D
As Astellas pivots through several candidates in an attempt to create its next blockbuster, a decision to terminate its only prospect in the core mitochondrial R&D area leaves very few other competitors in the market.
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